MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2007-05-25 for SMALL SINGLE EXTERNAL NASAL SPLINT 25/BOX 1528110 manufactured by Medtronic Ent.
[614908]
Received complaint report from another country: pt underwent an external septorhinoplasty and reconstruction of the valve using medpore graft in 2007. Surgeon applied steri strips and splint as per instructions and he checked that there was good perfusion to the nasal tip. One week later, at the post op visit, the splint was removed an ulcer the size of a 5 cent coin was evident. The pt. Was placed on oral and antibiotics and was receiving hyperbaric oxygen.
Patient Sequence No: 1, Text Type: D, B5
[7959742]
The contact returned 3 boxes of nasal splints 1528110(small), 1528120( med) and 1528137 (large). Returned items (nasal splints & dorsum pads) appeared to have been manufactured per the specifications; no defects found. Review of device history record does not indicate any discrepancies in product or in bill of materials. The root cause for patient's outcome is indeterminate at this time, although, based on the patient's anatomy, it is believed that the surgeon may have used a splint that was too small. The product ifu states that "post-operative edema may add to the splint pressure and may require adjustment in the first few days after surgery. " there is no indication from the available information that the patient was seen before one week post-operatively for splint adjustment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2007-00003 |
| MDR Report Key | 855601 |
| Report Source | 00,05 |
| Date Received | 2007-05-25 |
| Date of Report | 2007-05-25 |
| Date of Event | 2007-04-16 |
| Date Mfgr Received | 2007-05-07 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2007-06-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BILLY WIGGINS |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328196 |
| Manufacturer G1 | MEDTRONIC ENT |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL SINGLE EXTERNAL NASAL SPLINT 25/BOX |
| Generic Name | NON-STERILE DISPOSABLE NASAL SPLINT |
| Product Code | EPP |
| Date Received | 2007-05-25 |
| Returned To Mfg | 2007-05-21 |
| Model Number | 1528110 |
| Catalog Number | 1528110 |
| Lot Number | 40951000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 841787 |
| Manufacturer | MEDTRONIC ENT |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-25 |